Resumen

QUINTERO, Miguel et al. Bioequivalence of a dose of Levofloxacin LETI Laboratories (LL) tablets of 500 mg versus Levofloxacin SANOFI AVENTIS Laboratories: Tavanic^® (LSA) tablets of 500 mg administered in single dose in healthy volunteers. AVFT [online]. 2012, vol.31, n.1, pp.17-22. ISSN 0798-0264.

Objective: To evaluated the bioequivalence in 12 healthy volunteers of the LETI Laboratories Levofloxacin (LL) tablets 500 mg single dose, test product with the product Reference: SANOFI AVENTIS Laboratories Levofloxacin, Tavanic^® (LSA) 500 mg tablets. Methods: The test group received one tablet of levofloxacin LETI Laboratories (LL) of 500 mg, and the control group received a tablet Levofloxacin SANOFI AVENTIS Laboratories: Tavanic^® (LSA) of 500 mg. After this first treatment phase, volunteers received no medication for 6 consecutive days (washout period). Then he proceeded to the crossing of the treatments, the volunteers of the group test group received the medication reference and viceversa. The venous blood collection was performed at time 0, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 14, 18 and 24 hours. We determined plasma levels of levofloxacin in plasma samples from the clinical study, using HPLC chromatographic method developed and validated. Results: Cmax of 1253.40 + / -562.58 μg/mL for the LL vs. 1317.42 + / -439.64 μg/mL for LSA, the AUC_0-24 was 9188.43 + / -2406.64 μg/mL/h vs. 8780.22 + / -2305.99 μg/mL/h, and the AUC_0-∞ the result was 9933.17 + / -2488.52 μg/mL/h vs. 9433.47 + / -2399.71 μg/mL/h, respectively. The mean and confidence intervals for Cmax and AUC_0-24 and AUC_0-∞ were maintained in the range accepted for the demonstration of bioequivalence. Conclusions: Both products are bioequivalent and therefore interchangeable.

Palabras clave : Levofloxacin; bioequivalence; pharmacokinetics.